TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE)— 510(k) K030828

Name: FDA 510(k) clearance K030828
Creator: U.S. Food and Drug Administration
Published: 2003-05-21

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K030828 for TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE), Substantially Equivalent on 2003-05-21. Applicant: Beckman Coulter, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code GKZ
Device class: Class 2
Regulation: 21 CFR 864.5220
Advisory panel: Hematology
Date received: 2003-03-14
Decision date: 2003-05-21
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GKZ

view all

K253212 — XR-Series (XR-10, XR-20) Automated Hematology Analyzers2026-05-27
K243348 — Athelas Home2026-02-06
K251249 — Tru Hematology Test2026-01-16
K250943 — Sysmex XR-Series (XR-10) Automated Hematology Analyzer2025-06-25
K251371 — Sysmex XR-Series (XR-20) Automated Hematology Analyzer2025-06-25

More clearances from Beckman Coulter, Inc.

view all

K252169 — Access BNP II2026-03-24
K254059 — Access anti-HBc IgM2026-03-13
K253687 — Access anti-HBc Total2026-02-19
K251995 — Access anti-HAV IgM2026-01-27
K250588 — Access Rubella IgG2025-11-17

Adverse events under product code GKZ

product code GKZ

Malfunction: 1,205
Total: 1,205

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K030828

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K030828.

Data sourced from openFDA. This site is unofficial and independent of the FDA.